Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension

Exclusion Criteria

• •Participation in any clinical investigational drug study within the previous 12 weeks
• •Concomitant treatments with:
• •1. Any anti-hypertensive treatment other than Valsartan 80 mg
• •2. Cytochrome P450-3A4 inhibitors or inducers
• •3. Potassium-sparing diuretics
• •Severe hypertension (DBP \>/= 110 mm Hg and/or SBP \>/= 180 mm Hg) and/or evidence of secondary forms of hypertension
• •Any of the following cardiovascular diseases:
• •History of cardiovascular shock
• •Myocardial infarction or unstable angina within the previous 6 months
• •Severe cardiac valve disease
• •Past or present severe rhythm or conduction disorder.
• •Cerebrovascular ischemic event and/or history of intracerebral hemorrhage or subarachnoid hemorrhage (SAH) within the previous 12 months
• •Type 1 or 2 diabetes mellitus
• •Proteinuria
• •Uncorrected hypokalemia or hyperkalemia, sodium depletion and/or hypovolemia
• •Gastrointestinal disease resulting in the potential for malabsorption and/or severe gastro-intestinal tract narrowing; kock pouch (ileostomy after proctocolectomy)
• •Cholestasis or biliary obstruction
• •Liver disease or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels \>3 x upper limits of normal (ULN)
• •Renal failure, creatinine level \>2.0 mg/dl